The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Merete Metafix Small Fragment Bone Plate System.
| Device ID | K050457 |
| 510k Number | K050457 |
| Device Name: | MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | MERETE MEDICAL GMBH 269 WEST SEVENTY-FIRST STREET New York, NY 10023 |
| Contact | Jenik Radon |
| Correspondent | Jenik Radon MERETE MEDICAL GMBH 269 WEST SEVENTY-FIRST STREET New York, NY 10023 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-23 |
| Decision Date | 2005-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841742121819 | K050457 | 000 |
| 04048266024404 | K050457 | 000 |
| 04048266024411 | K050457 | 000 |
| 04048266024442 | K050457 | 000 |
| 00841742121727 | K050457 | 000 |
| 00841742121734 | K050457 | 000 |
| 00841742121741 | K050457 | 000 |
| 00841742121758 | K050457 | 000 |
| 00841742121765 | K050457 | 000 |
| 00841742121772 | K050457 | 000 |
| 00841742121789 | K050457 | 000 |
| 00841742121796 | K050457 | 000 |
| 00841742121802 | K050457 | 000 |
| 04048266024459 | K050457 | 000 |